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Conference
"Simplification of Treatment" Dr. Mona Loutfy (biography) English - 2003-03-29 - 46 minutes
Summary : Adherence to antiretroviral therapy is one of the most important factors influencing the effectiveness of HIV treatment. Higher adherence rates, even more than 95%, have been uniformly shown to lead to increased rates of virologic and immunologic success. The reasons for non-adherence with antiretroviral therapy are complex and vary from patient to patient. Regimen characteristics such as frequency of dosing , pill burden, number of different drugs, size of pills, food, water and refrigeration requirements, short- and long-term side effects, and ability to incorporate the treatment regimen into a daily routine have all been shown to significantly influence patient adherence and outcomes.
Since adherence is so important to achieving treatment success, various approaches to maximize adherence including antiretroviral amplifications have been proposed and studied. Since initial efforts to simplify regimens have shown some improvements in outcomes, the goal has become the development of ultra-simple, well-tolerated, low-pill-burden antiretroviral regimens. In fact, the Department of Health and Human Services has recognized this need for simplification and has indicated in their new guidelines that, “ To the extent possible, HAART regimens should be simplified by reducing the number of pills and the frequency of therapy, and by minimizing drug interactions and side effects.”
There are presently several different strategies for antiretroviral treatment simplification. These strategies include once-daily dosing, combining several medications into one pill to reduce pill burden, increasing the drug dose per pill to reduce pill burden, switching to new drugs or classes to reduce side effects and temporary short or long treatment interruptions. There are several antiretroviral agents that are approved for once-daily use and many more being investigated. The agents, which are approved for once-daily use, include tenofovir DF, didanosine tablets and enteric-coated (EC) and efavirenz. The agents, which have been or are being tested for once-daily dosing, include stavudine XR, lamivudine, abacavir, emtricitabine, nevirapine, atazanavir, saquinavir/ritonavir, amprenavir/ritonavir, pro-amprenavir and lopinavir/ritonavir. Many other agents are in phase I and II studies. Two drugs have combined antiretroviral agents into one pill, Combivir and Trizivir and have greatly contributed to simplification. Several new drugs are being released to increase the drug dose per pill to reduce pill burden including a 600-mg efavirenz preparation and pro-amprenavir, which is a precursor of amprenavir and significantly reduces the pill burden. There have been many switch studies to assess the effects of switching to a more tolerable regimen. Finally, many clinicians are stopping therapy in patients with a relatively high CD4 counts and plan to restart therapy at a later date in order to reduce toxicity.
Although simplified antiretroviral regimens have many advantages, there are still several potential drawbacks. One of the most serious problems is the potential for sub-optimal blood drug levels with less frequent dosing. The negative impact of missing a drug dose is greater in a once-daily regimen than in a multiple-dose daily regimen. Missing a dose of medication in a multiple-dose schedule leaves patients unprotected for only several hours while once-daily regimen may leave patients unprotected for an extended period. This can lead to insufficient viral inhibition and emergence of drug-resistant strains of HIV-1. Another problem with simplification is the potential for lack of potency of some simplified regimens. The issues are likely to be less important with combinations such as tenofovir DF, 3TC and efavirenz, which has been shown to be highly potent.
The importance of treatment simplification to the management of HIV cannot be overestimated and this area will continue to be at the forefront of HIV research. Particularly since antiretroviral simplification is not only likely to improve virologic response and durability but also quality of life. Further research is needed in this area to determine the efficacy, safety, potency and durability of simplified strategies.
Learning objectives : The participant will learn the important reasons for treatment simplification, i.e,
- Improved adherence and QOL
- Patients’ preference
- Maintenance of viral suppression
Also, an in-depth review of simplification strategies is covered:
- Once daily
- Reduced pill burden
- Switching
Bibliographic references : Treatment-related factors and highly active antiretroviral therapy adherence.
Trotta MP, Ammassari A, Melzi S, Zaccarelli M, Ladisa N, Sighinolfi L, Mura MS, d'Arminio Monforte A, Antinori A; AdICoNA Study Group.
Istituto Nazionale per le Malattie Infettive, L. Spallanzani IRCCS, Roma, Italy.
Adherence to highly active antiretroviral therapy (HAART) plays a critical role in the effectiveness of HIV treatment. Nevertheless, the complexity of regimens and frequent side effects make HAART extraordinarily difficult to take, and many HIV-infected persons fail to adhere. The current study offers an overview of the relationship between adherence and antiretroviral treatment-related variables. As for other chronic diseases, medication regimen complexity also has an impact on adherence in the management of HIV infection. In particular, the authors discuss the effect of pill burden, dosing frequency, dietary instructions, number and type of different medications prescribed, short- and long-term side effects, convenience, and ability to incorporate the treatment regimen into a daily routine. Medication side effects are common in HAART-treated persons and are associated with concurrent and future nonadherence. Simplification of regimens, adjustment of the drug schedule to the patient's specific lifestyle, and anticipation and self-management of side effects are treatment-based strategies to optimize HAART adherence and ensure the most effective, convenient, safe, and well-tolerated antiretroviral treatment.
J Acquir Immune Defic Syndr 2002 Dec 15;31 Suppl 3:S128-31
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